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# CDER Expectations for CGMP, Data Integrity
- URL: https://www.fdaweb.com/cder-expectations-for-cgmp-data-integrity/
- Published: 2017-06-06T12:00:00.000Z
- Updated: 2026-09-14T22:27:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138867

Two CDER staffers from the Office of Compliance and Office of Pharmaceutical Quality [discussed](https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM561491.pdf?ref=fdaweb.com) the Center’s expectations for data integrity and compliance with CGMP at the Society of Quality Assurance annual meeting. They said that 2016 enforcement actions, not including compounding-related action, involved 47 import alerts, 4 Untitled Letters, 54 Warning Letters, 27 instances involving regulatory discretion, and 27 regulatory meetings.

Much of the discussion involved data integrity, which was defined as a requirement that data are complete, consistent, and accurate. The acronym ALCOA was shared — attributable, legible, contemporaneous, original/true copy, and accurate.

Current Good Manufacturing Practices (CGMP) are minimum requirements, the speakers said, and data integrity underpins CGMP. They noted that requirement for record retention and review do not differ by data format; paper-based and electronic data record-keeping systems are thus subject to the same requirements.

Data integrity concepts covered in the presentation with definitions and case studies were metadata, audit trail, static versus dynamic records, backup data, and system validation.